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Recent Advances In The Development Of Innovative Therapies. The Celgene Pipeline Jean Caraux, MD PhD BTG, Hong Kong - February 23 th 2013.

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Presentation on theme: "Recent Advances In The Development Of Innovative Therapies. The Celgene Pipeline Jean Caraux, MD PhD BTG, Hong Kong - February 23 th 2013."— Presentation transcript:

1 Recent Advances In The Development Of Innovative Therapies. The Celgene Pipeline Jean Caraux, MD PhD BTG, Hong Kong - February 23 th 2013

2 2 Targeting Unmet Medical Needs Hematologic Malignancies Myeloma CLL NHL MDS AML MF B-Cell Malignancies T-Cell Malignancies MDS and Myeloproliferative disorders REVLIMID POMALYST ISTODAX REVLIMID VIDAZA POMALYST CTCL PTCL

3 3 Targeting Unmet Medical Needs Solid tumors Metastatic Breast Cancer NSCLC High Medical Need Malignancies Pancreatic Cancer Melanoma Abraxane

4 4 Major Recent Accomplishments Multiple Myeloma Lenalidomide (REVLIMID ® ) Approved in China for RRMM, Reimbursed in Taiwan Pomalidomide (POMALYST ® ) Achieved an overall survival benefit in a Ph III trial for RRMM after failure of prior options Approved in the US Access for Asian patients being set up

5 5 5 Pomalidomide-dex vs dex (phase III) Improved Overall Survival n= 455 HR=0.53

6 6 Global phase III trial fully accrued; Data expected H1:13 Combination of pomalidomide and prednisone is active in myelofibrosis 62% of patients achieved transfusion independence Pomalidomide : Myelofibrosis

7 7 Major Recent Accomplishments Lymphomas MCL : Lenalidomide filed for approval in US FL : R 2 highly active in first-line, phase III ongoing DLBCL : R 2 -CHOP21 is active and well tolerated. MDS and AML CC-486 (oral aza) : Initiated Ph III program, Chronic hypomethylation

8 8 Major Recent Accomplishments Nab-paclitaxel (ABRAXANE ® ) NSCLC : approved (US) Pancreatic Cancer : Demonstrated an overall survival benefit in Ph III trial Melanoma : Achieved the primary endpoint of PFS with OS trend in Ph III trial

9 9 Metastatic Melanoma : Abraxane Improved PFS in phase III vs dacarbazine 529 pts nab-Paclitaxel superior to standard DTIC chemotherapy PFS (primary endpoint) : –significantly improved vs dacarbazine –4.8 vs 2.5 months (P = 0.044) OS : –Interim OS analysis : trend in favor of the nab- paclitaxel arm –Observed early and maintained throughout the study

10 10 Pancreatic : Abraxane + Gemcitabine Improved Overall Survival in phase III Variable ABI- 007/Gemcitabine (N=431) Gemcitabine (N=430) Hazard Ratio HR A+G/G a P-value b Deaths333 (77%)359 (83%) Censored98 (23%)71 (17%) Median (months) % Confidence Interval – Survival Rate (%) at 6 month67%55% 9 month48%36% 12 month35%22% 18 month16%9% 24 month9%4% a 95% CI from stratified Cox model b Stratified log-rank using IVRS strata of region, KPS, and presence of liver mets Confidential – for internal use only 10

11 11 Near-term Milestones Apremilast Advantages 11 Targets high unmet need Clinical activity in several inflammatory diseases Safe and well tolerated Convenient – oral Psoriatic Arthritis Large Underserved Patient Populations ~ 6M patients in US / EU only Ph III ESTEEM data in psoriasis expected in Q1 Ph III PALACE-4 data in treatment- naïve PsA expected in Q1 Submit NDA for PsA in H1 ~1M~2.5M Ankylosing Spondylitis Psoriasis (moderate to severe) PsA Apremilast Adressing Frequent Unmet Needs

12 12 CC-292 (Avila) Potential of BTK Inhibition Osteoclasts RA, IBD Leukemia, Lymphoma SLE, ITP Vasculitides Allergy, MS Asthma, RA RA, Multiple Myeloma, Osteolytic Bone Disease MonocytesB CellsMast Cells

13 13 Focused Research and Early-Stage Development 13 Highlights Leverage Strategic Collaborations & Disruptive Technologies Advanced 7 programs into Ph I over last 2 yrs Expanded biologics program Enhanced platforms to accelerate discovery ARRY-111 ARRY-382 ACE-011 ACE-536 Cancer Metabolism Cancer Stem Cell Targets Genetic Lesion DOT1L + HMTs Novel Antibody Targets Ca ImmunoRx Target Exploit Our Unique Advantages IMiD technology platform Epigenetics Kinase inh. (TORKi, DNAPKi) Tumor progenitors Avilomics – protein silencing Antibody Conjugates

14 Thank you February 3013


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